Under the Human Tissue Act, the HTA has the power to issue its expected standards (or Directions) to establishments. This means that the HTA can issue general Directions to establishments to take into account changes in policy and legislation. The HTA may also make Directions that are specific to a particular establishment.
Directions 001/2021
The Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007 (as amended).
These Directions revoke Directions 002/2018.
- Directions 001/2021
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HTA guide to Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment v3
Directions 003/2020
Directions on bringing into force amended Code of Practice on the Human Transplantation (Wales) Act 2013 (second edition).
Directions 002/2020
Directions on bringing into force amended Code of Practice A: Guiding principles and the fundamental principle of consent (second edition) and amended Code of Practice F: Donation of solid organs and tissue for transplantation (fourth edition)
Directions 001/2020
Directions on licence fee structure for the financial year 2020/21
These Directions revoke Directions 001/2019
Directions 006/2019
Directions requiring establishments in the Research sector to submit a compliance update
Directions 005/2019
Directions requiring establishments in the Public Display sector to submit a compliance update
Directions 004/2019
Directions requiring establishments in the Post Mortem sector to submit a compliance update
Directions 003/2019
Directions requiring establishments in the Organ Donation and Transplantation sector to submit a compliance update
Directions 002/2019
Directions requiring establishments in the Anatomy sector to submit a compliance update
Directions 001/2019
Directions on licence fee structure for the financial year 2019/20.
These Directions revoke Directions 001/2018.
Directions 002/2018
The Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007 (as amended).
These Directions revoke Directions 003/2010
- Directions 002/2018
- HTA guide to Quality and Safety Assurance for Human Tissue and Cells for Patient Treatment v2
Directions 001/2018
Directions on licence fee structure for the financial year 2018/19.
These Directions revoke Directions 001/2017.
Directions 007/2017
Directions requiring establishments in the Research sector to submit a compliance update
Directions 006/2017
Directions requiring establishments in the Public Display sector to submit a compliance update
Directions 005/2017
Directions requiring establishments in the Post mortem sector to submit a compliance update
Directions 004/2017
Directions requiring establishments in the Organ Donation sector to submit a compliance update
Directions 003/2017
Directions requiring establishments in the Anatomy sector to submit a compliance update
Directions 002/2017
Directions bringing into effect revised editions of codes of practice and a new code of practice.
These Directions revoke Directions 002/2009
Directions 001/2017
Directions on licence fee structure for the financial year 2017/18.
These Directions revoke Directions 001/2016.
Directions 001/2016
Directions on licence fee structure for the financial year 2016/17.
These Directions revoke Directions 001/2015.
Directions 007/2015 - Research
Directions bringing into force compliance reporting for establishments with an HTA research licence.
Directions 006/2015 - Post Mortem (Storage of relevant material only)
Directions bringing into force compliance reporting for establishments with an HTA post mortem licence.
Directions 005/2015 - Public Display
Directions bringing into force compliance reporting for establishments with an HTA public display licence.
Directions 004/2015 - Anatomy
Directions bringing into force compliance reporting for establishments with an HTA anatomy licence.
Directions 003/2015
Directions requiring establishments in the organ donation and transplantation sector to submit a compliance update to the HTA
These Directions come into force on the 28 September 2015, and remain in force until revoked
Directions 002/2015
Directions requiring establishments in the post mortem sector to submit a compliance update to the HTA
These Directions come into force on the 10 July 2015, and remain in force until revoked
Directions 001/2015
Directions on licence fee structure for the financial year 2015/16.
These Directions revoke Directions 001/2014.
Directions 001/2014
Directions on licence fee structure for the financial year 2014/15.
These Directions revoke Directions 001/2013.
Directions 005/2013
Directions bringing into force compliance reporting for establishments with an HTA public display licence.
- Directions 005/2013
- Covering letter to the public display sector October 2013
- Guidance document - public display sector
Report via the HTA Portal, new users can register here and existing users can log in here.
Directions 004/2013
Directions bringing into force compliance reporting for establishments with an HTA anatomy licence.
- Directions 004/2013
- Covering letter to the anatomy sector October 2013
- Guidance document - anatomy sector
Report via the HTA Portal, new users can register here and existing users can log in here.
Directions 003/2013
Directions bringing into force compliance reporting for establishments with an HTA research licence.
- Directions 003/2013
- Covering letter to the research sector October 2013
- Guidance document - research sector
Report via the HTA Portal, new users can register here and existing users can log in here.
Directions 002/2013
Directions bringing into force compliance reporting for establishments with an HTA post mortem licence.
- Directions 002/2013
- Covering letter to the PM sector August 2013
- Guidance document - post mortem sector
Report via the HTA Portal, new users can register here and existing users can log in here.
Directions 001/2013
Directions on licence fee structure for the financial year 2013/14.
These Directions revoke Directions 001/2012.
Directions 003/2012
Directions given under Regulations 6 and 11 of the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (SI 2012 no.1501) bringing into effect HTA’s Organs Intended for Transplantation – a documentary framework.
Directions 002/2012
Directions on the removal of tissue from the body of a deceased person.
Directions 001/2012
Directions on licence fee structure for the financial year 2012/13.
These Directions revoke Directions 001/2011.
Directions 002/2011
Directions bringing into force a self assessment by establishments with an HTA Anatomy, Public Display or Research licence.
- Covering letter April 2011
- Directions 002/2011
- Reference document - Anatomy updated 10 May 2011 - guidance update for questions 8 and 9
- Reference document - Public Display sector
- Reference document - Research sector
- Online form (HTA01-002/2011)
Directions 001/2011
Directions on licence fee structure for the financial year 2009/10.
These Directions revoke Directions 001/2007 and 001/2008 and 001/2009
Directions 003/2010
The Directions consolidate and clarify the standards required under the Human Tissue (Quality and Safety of Tissues and Cells for Human Application) Regulations 2007.
These Directions revoke Directions 001/2006, 002/2007 and 004/2007
- Covering letter
- Directions 003/2010
- Guide to quality and safety assurance of human tissues and cells for patient treatments
Directions 001/2010
Directions bringing into force annual compliance reporting for establishments with an HTA Post Mortem licence.
Report via the HTA Portal, new users can register here and existing users can log in here.
Directions 002/2009
Directions bringing into force HTA codes of practice.
These Directions revoke Directions 002/2006
Directions 001/2009
Directions on licence fee structure for the financial year 2009/10.
These Directions revoke Directions 001/2007 and 001/2008
Directions 001/2009
Directions 001/2008
Directions on interim licence fee structure for procurement for human application licences 2008/09
These Directions have been revoked by Directions 001/2009
Directions 004/2007
Directions issued to comply with Regulation 15 (1) of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. These Directions come into force on 7 October 2007 and apply only to imports from non European Economic Area (EEA) states.
These Directions have been revoked by Directions 003/2010
Directions 003/2007
Directions on bringing into force the HTA's Import and Export code of practice
Directions 002/2007
Directions given under the Human Tissue Act 2004 implementing the Human Tissue (Quality and Safety for Human Application) Regulations 2007 which implement the requirements of the EUTCD (the parent directive) and the European Commission's first and second technical directives of the parent directive.
These Directions have been revoked by Directions 003/2010
Directions 001/2007
Directions on licence fee structure 2006/07 and 2007/08
These Directions have been revoked by Directions 001/2009
Directions 002/2006
Directions bringing into force certain HTA codes of practice.
These Directions have been revoked by Directions 002/2009
Directions 001/2006
Directions implementing the requirements of the EU Tissue and Cells Directive (the parent directive) and the European Commission's first technical directive of the parent directive.
These Directions have revoked by Directions 003/2010